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Adverse Event Reporting for Combination Products Bradley Merrill Thompson Leighton Hansel Colleen Hittle FDA’s concept paper • General principles – For most combination products, appropriate AE reporting may be achieved by following the regulatory provisions associated with the type of marketing application used for approval. – But this does leave gaps. • For example, following the MDR for a drug/device combination would leave out some important drug type information. Differences in AE reporting schemes • Device malfunction reporting • Five day MDR reporting • Drug and biological product “alert” reporting • Blood related deaths FDA’s conceptual alternatives • Combination products approved under one marketing application. – For these, FDA could simply require that the manufacturer follow the rules associated with the marketing application. • Combination products approved under separate marketing applications. – If both applications filed by the same manufacturer, where the most likely part associated with the incident can be identified, the manufacturer would follow the rules associated with that part. – If not, the manufacturer would follow the rules associated with the lead review Center. – If the two applications are filed by separate manufacturers, each manufacturer would file according to the marketing application used for the part they made. – FDA is unsure of what to do when a manufacturer believes that the other manufacturer has the responsibility. CPC Comments • Let’s remember that combination products come in three flavors: – Cross labeled – Kits – Single entity • CPC in its comment letter put together a table showing how interim and unified safety reporting systems could be accomplished. Conceptual alternatives Option Basic rule 1 2 3 File Always FDA based file two should on the use subdiscretion mission to decide or at the center time of type approval 4 5 6 The manufacturer should have the discretion to decide which best applies Always file 1½, that is a primary submission and a supplemental submission FDA should develop a single unified reporting process for combination products Questions or comments? Questions or comments?